Sr CTM

Job Description: Summarized Purpose:

•Hiring manager will consider a Sr CTM or a Project Lead. With either, must have global experience.

Global Sr CTM is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract Product, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.

Essential Functions:
Manages all clinical operational and quality aspects of allocated studies, ofmoderate to high complexity, in compliance with ICH GCP. In accordance toproject specific requirements, may assume Lead CTM responsibilities on regionallevel, Clinical Study Manager (CSM) responsibilities or take on additionalresponsibilities; e.g. process improvements, manage complex programs, havewider management or project coordination responsibilities.
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) inconjunction with the Data Quality Plan. Contributes to the development of theMaster Action Plan (MAP) for providing clinical related documents. Ensurestimely set up, organization, content and quality of the relevant sections of theTrial Master File (local and central). May participate in the design anddevelopment of CRFs, CRF guidelines, patient informed consent templates andother protocol specific documents as required. Collaborates with the projectmanager to prepare, organize, and present at client meetings, including biddefense and hand-off meetings.
Collaborates with the clinical team and other departments as needed to meetdeliverables of the project. Regularly communicates with the team and leadsteam meetings to ensure that timelines, resources, interactions, and quality aremaintained. Responsible for the implementation and training of standardizedclinical monitoring processes within the study and according to corporatestandard policies. Responsible for the timely archiving of documents and studymaterials for the department.
Ensures achievement of the final clinical deliverable within the contractual timeperiod specified by preparing and monitoring clinical activity timelines andmetrics, providing status updates to the project manager, regularly reviewingprojects using tracking and management tools, implementing recovery actions,reviewing monitoring visit reports, and managing CRF collection and queryresolution. Continuously monitors clinical trials to assess performance and ensurecontractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.
Communicates with study sites regarding issues such as protocol, patientparticipation, case report form completion and other study-related issues.
May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
Solid understanding of change management principles
Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
Strong judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating own and team members workload aProductst project budget and adjust resources accordingly
Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Capable of independently managing clinical only studies


Comments for Suppliers: *Hiring manager will consider a Sr CTM or a Project Lead. With either, must have global experience.
5+ years in the pharmaceutical industry and/or clinical research organization. 3+ years as clinical study manager (global oversight), with significant study management support experience. Must have extensive GLOBAL study experience outlined on resume to be considered. Will support study management in subset of activities (i.e., vendor management, inspection readiness, various activities of study management). The candidates must have global experience as project/study manager and ability to run trials on their own.